Fetal Aortic Valvuloplasty for Hypoplastic Left Heart Syndrome

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Mauro H. Schenone

Disqualifiers: Age, Anesthesia, Preterm labor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fetal Aortic Valvuloplasty for Hypoplastic Left Heart Syndrome?

Research suggests that fetal aortic valvuloplasty can help prevent the progression of severe aortic stenosis (a narrowing of the heart's aortic valve) to hypoplastic left heart syndrome, potentially improving heart growth and function before birth. ^{1 2 3 4 5}

Is fetal aortic valvuloplasty generally safe for humans?

Fetal aortic valvuloplasty is considered a high-risk procedure, and careful selection of candidates is important to minimize risks. The procedure has been performed in several cases, but it carries potential risks related to the intervention itself. ^{1 2 3 4 6}

How is fetal aortic valvuloplasty different from other treatments for hypoplastic left heart syndrome?

Fetal aortic valvuloplasty is unique because it is performed before birth to prevent the progression of severe aortic stenosis (narrowing of the heart's aortic valve) to hypoplastic left heart syndrome, potentially improving the growth and function of the left heart. This prenatal intervention aims to alter the natural course of the condition, unlike traditional treatments that are typically administered after birth. ^{1 2 3 4 7}

What is the purpose of this trial?

The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).

Research Team

Mauro Schenone, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for pregnant women aged 18-45 with a fetus diagnosed with evolving hypoplastic left heart syndrome (HLHS). The mother must be healthy for surgery, between 21 and almost 30 weeks pregnant. Criteria include specific measurements of the fetal heart's structure and function indicating potential for successful treatment.

Inclusion Criteria

I am healthy enough for surgery.

Gestational age between 21 0/7 and 29 6/7 weeks of gestation

My main heart issue is related to the heart valves.

Exclusion Criteria

Cases with all the following criteria: Left ventricle pressure ≤ 47 mmHg, MV dimension Z-score < 0.1, MV inflow time Z-score < -2

I cannot have surgery or anesthesia due to health risks.

Preterm labor or cervical length <20 mm at enrollment or uterine anomaly strongly predisposing to preterm delivery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fetal aortic valvuloplasty is performed between 21 and 29 weeks gestation to increase the size of the baby's aortic valve

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fetal Aortic Valvuloplasty

Trial Overview The study tests fetal aortic valvuloplasty using specialized catheters like Emerge Monorail, Over-The-Wire PTCA Dilatation Catheter, Trek RX, and Mini Trek RX to manage HLHS in fetuses. It aims to find out if this can improve outcomes by promoting normal left heart development.

Participant Groups

Group I: Intervention Group: Fetal Aortic Valvuloplasty Experimental Treatment 3 Interventions

Women diagnosed with HLHS will undergo fetal aortic valvuloplasty between 21 and 29 weeks gestation.

Group II: Control Group: Expectant Management Active Control 1 Intervention

Women diagnosed with HLHS will undergo expectant management with postnatal surgery.

Who Is Running the Clinical Trial?

Mauro H. Schenone

Lead Sponsor

Trials

2

Recruited

100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Fetal intervention for critical aortic stenosis: advances, research and postnatal follow-up. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Foetal aortic valvuloplasty: experience of five cases. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Which is the best time to perform balloon valvuloplasty in critically fetal aortic stenosis: Prenatally or after birth? [2022]

4. England pubmed.ncbi.nlm.nih.gov

Intrauterine aortic valvuloplasty in fetuses with critical aortic stenosis: experience and results of 24 procedures. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Fetal hemodynamic response to aortic valvuloplasty and postnatal outcome: a European multicenter study. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Natural history of 107 cases of fetal aortic stenosis from a European multicenter retrospective study. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Fetal aortic valve stenosis and the evolution of hypoplastic left heart syndrome: patient selection for fetal intervention. [2019]